On February 18, 2026, FDA leadership signaled a major shift in how effectiveness is demonstrated for most drugs: the default expectation will be one adequate and well-controlled pivotal study, paired with confirmatory evidence, rather than [...]
On February 2, 2026, FDA’s revised 21 CFR Part 820 - now titled the Quality Management System Regulation (QMSR) - became effective. The key change is that FDA now incorporates ISO 13485:2016 by reference as [...]
FDA closed out 2025 - and opened the door to 2026 - with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s [...]
Across medical device and IVD inspections, U.S. Food and Drug Administration (FDA) continues to issue Form 483 observations and Warning Letters tied to risk management failures. These findings are not about missing templates, they reflect systemic breakdowns in how risk is identified, evaluated, justified, and maintained. Below are the three [...]
FDA closed out 2025 with a meaningful update for device sponsors: the final guidance, “Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices,” issued December 18, 2025, which supersedes the prior 2017 version. At QSN, we see this as more than a “nice-to-have” document. It’s a clearer [...]
With the February 2, 2026, implementation date for FDA’s Quality Management System Regulation (QMSR) quickly approaching, FDA has now issued a final rule making 179 technical amendments across Title 21 of the Code of Federal Regulations. These updates formally replace legacy Quality System Regulation (QSR) references with QMSR terminology throughout [...]
If you want to know where regulatory expectations are headed, you don’t always need a new guidance document. Sometimes you just need to listen to what regulatory pros keep arguing about. Across recent discussions, three themes keep surfacing again and again: How long to keep records in a world of [...]
The U.S. government shutdown has finally ended, and for the FDA, the relief is real. With Congress passing a funding bill covering the agency through September 30 of the next fiscal year, the agency now enjoys a measure of stability that reduces the risk of future funding lapses. But that [...]
The FDA’s updated guidance on Unique Device Identification (UDI) for combination products, updated as of June 2025, has stirred conversation across the industry. For companies developing products that merge drug, biologic, and device components, labeling has always been a regulatory gray zone. Now, the FDA’s latest updates, intended to clarify [...]
